A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Effects of Three Doses of the Dietary Supplement oréVida™ on Alertness, Attention and Concentration in Healthy Men and Women

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Addison,
Illinois60101

Purpose:

The purpose of this study is to investigate the effects of the dietary supplement oréVida™
(active ingredient on the basis of a culinary herb)administered twice daily in an acute
study on an improvement in vigilance, attention, concentration, memory and mood in 45
healthy men and pre-menopausal women, aged 35-50 years, inclusive.
oréVida™ is considered a dietary supplement, and therefore it is not an approved drug by the
Food and Drug Administration (FDA). It is regulated like a food. The U.S. Food and Drug
Administration does not strictly regulate herbs and dietary supplements. We do not claim
that this supplement is meant to treat any ailment.

Criteria:

Inclusion Criteria:
- Subject is a male or pre-menopausal female, 35-50 years, inclusive. Post-menopausal
is defined as a history of spontaneous amenorrhea for a period of 12 consecutive
months or six weeks post-surgical bilateral oophorectomy, with or without
hysterectomy.
- Subject is willing to maintain his or her habitual diet and usual physical activity
patterns throughout the study.
- Subject has no health conditions that would prevent him/her from fulfilling the study
requirements as judged by the Investigator on the basis of medical history and
routine laboratory test results.
- Subject has a body mass index (BMI) of ≥20.00 and <30.00 kg/m2
- Subject is willing to refrain from consuming alcohol 24 h prior to test days.
- Subject is willing to refrain from consuming caffeine and caffeine-containing
products 12 h prior to test days.
- Subject is willing to refrain from vigorous physical activity 12 h prior to test
days.
- Subject is a non-smoker.
- Subject understands the study procedures and signs forms providing informed consent
to participate in the study and authorization for release of relevant protected
health information to the study Investigator.
Exclusion Criteria:
- Subject has a positive drug screening of amphetamines, barbiturates, benzodiazepines,
cannabis, cocaine, methamphetamines, methadone, 3,4-methylenedioxymethamphetamine,
opiates or tricyclic antidepressants at screening.
- Subject has abnormal laboratory test results of clinical significance, including, but
not limited to: creatinine ≥1.5 mg/dL, or alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) ≥1.5X the upper limit of normal at screening.
- Subject has donated more than 300 mL of blood during the three months prior to
screening.
- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or
diastolic blood pressure ≥100 mm Hg) as defined by the average blood pressure
measured at screening. One re-test will be allowed on a separate day prior to visit
2, day 0 for subjects whose blood pressure exceeds either of these cut points at
visit 1.
- Subject has a history or presence of clinically important cardiac, renal, hepatic,
endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal,
pancreatic, or neurologic disorders that, in the judgment of the Investigator, would
interfere with the subject's ability to provide informed consent, comply with the
study protocol (which might confound the interpretation of the study results), or put
the subject at undue risk.
- Subject has a history, in the judgment of the Investigator, of a psychological
illness or condition such as to interfere with the subject's ability to understand
the requirements of the study.
- Use of any sleep aid medication within four days prior to each test day.
- Subject has a history or presence of cancer in the prior two years, except for
non-melanoma skin cancer.
- Subject is pregnant, planning to be pregnant during the study period, lactating, or
women of childbearing potential who are unwilling to commit to the use of a medically
approved form of contraception throughout the study period. The method of
contraception must be recorded in the source documentation.
- Excessive habitual caffeine consumption (>300 mg caffeine/d or ≥3 cups of caffeinated
coffee/d), following screening and throughout the study period.
- Use of any psychotropic medication within four weeks of screening and throughout the
study.
- Use of antibiotics or signs of active systemic infection. Treatment visits will be
rescheduled to allow the subject to wash off of the antibiotic for at least five days
prior to any test visit.
- Subject has had exposure to any non-registered drug product within 30 days prior to
the screening visit.
- Use of dietary supplements containing any of the following: ginkgo biloba, St. John's
wort, ginseng, gotu kola (Indian pennywort); daily doses of vitamin E (≥30 mg/d) or
folic acid (≥400 ug/d); thiamine, riboflavin, and/or pyridoxine (≥2 mg/d); and
eicosapentaenoic acid (EPA), docosahexaenoic acid or a combination of EPA + DHA (≥500
mg/d) within 2 weeks of screening visit.
- Recent history of (within 12 months of screening visit 1) or strong potential for
alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink
= 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Subject has a known allergy or sensitivity to study product or any ingredients of the
study product or meals provided.
- The subject is unable to perform the tests on the CDR System during training to the
established acceptable levels for participation in this type of study.

NCT ID:

NCT01143194

Primary Contact:

Principal InvestigatorKathleen Kelley, MDProvident Clinical Research

Backup Contact:

N/A

Location Contact:

Addison, Illinois 60101United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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